CARDIVA VASCADE MVP Manuel D'utilisation page 11

Conclusions of the Clinical Studies
The results from the AMBULATE Trial demonstrate that patients who underwent catheter-based procedures using 6–12F inner
diameter (15F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs and who were
treated with the Cardiva VASCADE MVP VVCS showed a statistically and clinically significantly shorter time to ambulation, total post-
procedure time and time to discharge eligibility compared to patients treated with manual compression. Additionally, VASCADE MVP
was non-inferior to manual compression with regard to time to haemostasis, the results statistically implying superiority.
In addition, the trial demonstrated that the rates of total combined major complications were clinically the same (0%) between the
VASCADE MVP VVCS and manual compression patients and that the rates of total combined minor complications were clinically similar
between the VASCADE MVP VVCS and manual compression patients (1.0% VVCS vs. 2.4% manual compression).
Finally, the procedure success rate for patients treated with the VASCADE MVP VVCS was similar to patients treated with standard
manual compression (98% VVCS vs. 99% manual compression). Patient satisfaction scores favoured the device and pain medication
use was lower in the device group compared to the manual compression group.
The results from the AMBULATE VASCADE MVP Same-Day Discharge Retrospective and Prospective Registries demonstrate that
VASCADE MVP is associated with same-day discharge in patients who underwent catheter-based procedures using 6–12F inner
diameter procedural sheaths, with single or multiple access sites in one or both limbs and who were treated with the VASCADE MVP
VVCS. This is demonstrated by the high success rate of all performance procedural outcomes and absence of major and low rate of
minor access site closure-related complications. Additionally, the high success rates of the procedural performance outcomes indicate
physicians were able to accurately assess patient eligibility for same-day discharge.
Page 11 of 24
IFU 5686 AE, 2024-04